Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Trial ID or NCT#

NCT04511026

Status

not recruiting iconNOT RECRUITING

Purpose

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Official Title

Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - The patient has histological diagnosis of cancer of the endometrium of any histology or grade. - The patient should have received no prior treatment for her endometrial cancer. - The patient has clinically uterine confined disease. - The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care. - The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2. - If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. - The patient has provided written informed consent. - The patient is at least 18 years of age at the time of consent
Exclusion Criteria:
  1. - The patient has clinical or radiological evidence of metastatic disease. - The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix. - The patient has participated in another investigational drug study within 30 days of scheduled surgery. - The patient has an iodine allergy. - The patient is pregnant or lactating.
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Investigator(s)

Amer Karam
Amer Karam
Gynecologic oncologist
Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology

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Contact

Sujatha Kalle
650-724-3308

View on ClinicalTrials.gov